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good sense tioconazole 1 6.5 g/100g Ointment, 1 pouch — NDC 00113-0426-54 package photo

good sense tioconazole 1 6.5 g/100g Ointment, 1 pouch

by L. Perrigo Company · 1 POUCH in 1 CARTON (0113-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
NDC 00113-0426-54
🏷️ FDA NDC (as labeled) 0113-0426-54 billing pads the labeler segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0113-0426-54
Product NDC 0113-0426
11-digit billing NDC 00113042654
NCPDP billing unit GM — per gram (weight)
RxCUI 198380
UNII S57Y5X1117
Application # ANDA075915
SPL Set ID d39ac447-6e1d-4b77-90c1-a9a653661f42
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-22
Route VAGINAL
Dosage form OINTMENT
Substance TIOCONAZOLE
GPI-14 55104075004220
GCN Seq No 012092
GCN 05280
HICL code 004569
Ingredient (HICL) Tioconazole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q4
Therapeutic class — intermediate (HIC2) Vaginal Preparations
HIC3 code Q4F
Therapeutic class — specific (HIC3) Vaginal Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name TIOCONAZOLE 1 6.5% OINTMENT
FDB brand name Tioconazole-1
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0113-0426-54 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00113-0426-54. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerL. Perrigo Company
Application holderL PERRIGO CO
FDA applicationANDA075915 (ANDA)
Labeler code00113
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio227 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TIOCONAZOLE 1 6.5% OINTMENT Ingredient Tioconazole
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

3 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbutylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $2.412 $11.10 / 4.6 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $2.434 $2.356
Flat over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense tioconazole 1 6.5 g/100gthis 00113-0426-54 L. 1 pouch $2.412 — Availability likely —
Leader Tioconazole 1 6.5 g/100g 70000-0357-01 Cardinal 1 applicator $2.412 — Availability likely —
foster and thrive tioconazole 6.5 g/100g 70677-1224-01 Strategic 1 applicator $2.412 — Availability likely —
Tioconazole 1 6.5 g/100g 00363-0426-54 Walgreen 1 pouch — — FDA listed —
Vagistat 6.5 g/100g 11509-0426-01 Combe 1 pouch — — FDA listed —
Up and up tioconazole 1 6.5 g/100g 11673-0426-54 Target 1 pouch — — FDA listed —
signature care tioconazole 1 6.5 g/100g 21130-0060-54 Safeway 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 21130-0781-54 Safeway 1 pouch — — FDA listed —
Topcare Tioconazole 1 6.5 g/100g 36800-0426-54 Topco 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 37808-0426-54 H 1 pouch — — FDA listed —
Equaline Tioconazole 1 6.5 g/100g 41163-0032-54 United 1 pouch — — FDA listed —
tioconazole 1 6.5 g/100g 41250-0426-54 Meijer 1 pouch — — FDA listed —
CareOne Tioconazole 1 6.5 g/100g 41520-0426-54 American 1 pouch — — FDA listed —
Equate tioconazole 1 day 6.5 g/100g 49035-0426-54 Wal-Mart 1 pouch — — FDA listed —
dg health tioconazole 1 6.5 g/100g 55910-0731-54 Dolgencorp 1 pouch — — FDA listed —
tioconazole 1 6.5 g/100g 59779-0718-26 CVS 1 pouch — — FDA listed —
Monistat Tioconazole 1 6.5 g/100g 63736-0413-01 Insight 1 applicator — — FDA listed —
basic care tioconazole 6.5 g/100g 72288-0426-54 Amazon.com 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 72288-0222-54 Amazon.com 1 pouch — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for good sense tioconazole 1 (this brand).

Top reported reactions

Vulvovaginal Burning Sensation518
Vulvovaginal Swelling290
Condition Aggravated225
Vulvovaginal Pain224
Vulvovaginal Pruritus195
Vulvovaginal Discomfort160
Vaginal Discharge59

Reporter sex

1,512 reports

Serious outcomes

Death19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 299 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00113-0426-54 You're viewing this 1 POUCH in 1 CARTON (0113-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR 2019-10-22 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 6 words ▾

Use • treats vaginal yeast infections

⏱️ Dosage and Administration 68 words ▾

Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • children under 12 years of age: ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS When using this product • do not use tampons, douches, spermicides, or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if • symptoms do not get better after 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 76 words ▾

Other information • this product is a 1-dose treatment. Most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. • if you have questions about vaginal yeast infections, consult your doctor • store at 20 ° -25 ° C (68 ° -77 ° F) • see end flap of carton for lot number and expiration date

🧪 Active Ingredient 9 words ▾

Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

🎯 Purpose 3 words ▾

Purpose Vaginal antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00113-0422-25 · L. 00113-0428-65 · L. →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.